Therapeutic composition and a method of coating implantable medical devices

a technology of medical devices and compositions, applied in the field of therapeutic compositions and a method of coating implantable medical devices, can solve the problems of limited solubility of agents with limited solubility in water and unstable under ambient conditions, adverse or toxic side effects for patients, and difficult measurement of the release rate of agents with limited solubility in water and stable under ambient conditions

Inactive Publication Date: 2007-03-22
ABBOTT CARDIOVASCULAR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to provide an efficacious concentration to the treated site, systemic administration of such medication often produces adverse or toxic side effects for the patient.
However, the rate of release of agents that have limited solubility in water and are unstable under ambient conditions is difficult to measure.
Everolimus has a very limited solubility in water, and is, in addition, quite unstable under ambient conditions, posing a serious obstacle for the study of the drug's release kinetics from a stent.
In addition, everolimus has limited stability in an aqueous medium.

Method used

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  • Therapeutic composition and a method of coating implantable medical devices

Examples

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example 1

[0034] About 600 μg everolimus was mixed with about 100 ml of distilled de-ionized water. The mixture containing about 6.0 μg / ml of everolimus was vigorously stirred while maintained at a temperature of about 37° C. The amount of dissolved everolimus was measured using HPLC immediately after mixing, and then after 24 and 120 hours, while continuing to keep the solution at about 37° C.

[0035] About 3.33 μg / ml of everolimus was found in the solution initially, or about 55.5 mass % of the starting amount everolimus mixed with water. After 24 hours, about 0.31 μg / ml was found to remain in the solution, or about 5.2 mass % the starting amount everolimus mixed with water. After 120 hours, no everolimus was found to remain in the solution.

example 2

[0036] About 600 μg everolimus was mixed with about 100 ml of a PBS buffer solution having pH of about 7.4. The mixture was stirred and tested as described in Example 1. About 3.1 μg / ml of everolimus was found in the solution initially, or about 51.7 mass % of the starting amount everolimus mixed with the buffer solution. After 24 hours, about 0.91 μg / ml was found to remain in the solution, or about 15.2 mass % the starting amount everolimus mixed with the buffer solution. After 120 hours, no everolimus was found to remain in the solution.

example 3

[0037] About 600 μg everolimus was mixed with about 100 ml of a PBS buffer solution having pH of about 7.4. The buffer solution contained about 1 mass % of the surfactant TWEEN 80. The mixture was stirred and tested as described in Example 1. About 6.13 μg / ml of everolimus was found in the solution initially, or about 102.1 mass % of the starting amount everolimus mixed with the buffer solution. After 24 hours, about 2.11 μg / ml was found to remain in the solution, or about 35.2 mass % the starting amount everolimus mixed with the buffer solution. After 120 hours, no everolimus was found to remain in the solution.

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Abstract

A method of making a therapeutic composition, as well as the therapeutic composition so made, is disclosed. The method comprises mixing a hydrophobic drug with an aqueous buffer solution and adding a surfactant to the aqueous buffer solution to form the therapeutic composition. A implantable medical device with the therapeutic composition and a method of making a coating for an implantable medical device containing the therapeutic composition is also disclosed.

Description

CORSS REFERENCE TO RELATED APPLICATION [0001] This is a continuation of U.S. application Ser. No. 10 / 316,739, filed on Dec. 10, 2002, the teachings of which are incorporated hereto by reference in their entirety.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to compositions such as those used for coating implantable medical devices such as stents. [0004] 2. Description of Related Art [0005] Stents are used not only as a mechanical intervention but also as a vehicle for providing biological therapy. As a mechanical intervention, stents act as scaffoldings, functioning to physically hold open the wall of the passageway. Stents are capable of being compressed, so that they can be inserted through small lumens via catheters, and then expanded to a larger diameter once they are at the desired location. Biological therapy for reducing or eliminating thrombosis or restenosis can be achieved by medicating the stents. Medicated stents provide for t...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F2/02
CPCA61L31/14A61L2300/802A61L2300/416A61L31/16
Inventor ZHANG, GINAHOSSAINY, SYED F.A.PARK, EUGENEWANG, QI
Owner ABBOTT CARDIOVASCULAR
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